Impact on healing of double-layered compression stocking in the treatment of severe venous leg ulcers: A prospective, multicenter, controlled trial

Abstract

Venous leg ulcer refers to chronic wounds, generally difficult to heal and often prone to recurrence. The objective of this research was to assess a double layered compression stocking VenoTrain® ulcertec on a population with mostly severe pathologies. This prospective, multicenter, interventional type II study was conducted between September 2018 and January 2022. Out of 124 patients enrolled, 97.6% had a history of previous leg ulceration, 72.6% were already being followed for leg ulcerations, 30.9% were severely overweight and 24.2% diabetic. Overall, a majority of target ulcers were present for 6 months or more, and the ulcer surface area was larger than 8 cm² in nearly one in every five cases. The primary endpoint was the rate of closed ulcer after a maximum follow-up of 20 weeks. While most of the treated venous leg ulcerations may be regarded as hard-to-heal wounds, closure rate at 20 weeks ranged between 50.0% (two severity criteria) and 69.0% (no severity criteria) according to baseline wound severity criteria. Besides, VenoTrain® ulcertec device was particularly well accepted and tolerated by patients. In 93.2% of visits, patients stated using it every day. When managing venous ulcerations not requiring strongly thick absorbent dressings, VenoTrain® ulcertec device represents an efficient and more suitable alternative to venous compression bandaging.